Cleared Traditional

K013179 - LUXAGLAZE

K013179 is the FDA 510(k) clearance for LUXAGLAZE by Dmg USA, Inc.. It is a Class 2 Dental device (product code EBD) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K013179 · Dmg USA, Inc. · Dental device
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Oct 2001
Decision
18d
Days
Class 2
Risk

K013179 is an FDA 510(k) clearance for the LUXAGLAZE. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Dover, US). The FDA issued a Cleared decision on October 12, 2001 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dmg USA, Inc. devices

Submission Details

510(k) Number K013179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2001
Decision Date October 12, 2001
Days to Decision 18 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 127d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBD Coating, Filling Material, Resin

All 38
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K013179.
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